BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 11214173 · Received January 22, 2021

    Report

    Report Number
    11214173
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    January 7, 2021
    Report Date
    January 12, 2021
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDLINE INDUSTRIES, INC. STANDARD SUCTION SWAB KITS WITH BIOTENE (ORAL SWAB) BROKEN OFF INSIDE THE PATIENT'S MOUTH. PART OF IT WAS NOT RETRIEVED. PATIENT TESTED POSITIVE FOR COVID-19 SO SWAB WAS NOT KEPT. THIS IS AN ONGOING PROBLEM WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114939 MEDLINE CATHETER AND TIP, SUCTION JOL MEDLINE INDUSTRIES, INC. MDS096513 20-211

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA